作者
Scott Kopetz, Jayesh Desai, Emily Chan, Joel Randolph Hecht, Peter J O'Dwyer, Dipen Maru, Van Morris, Filip Janku, Arvind Dasari, Woonbook Chung, Jean-Pierre J Issa, Peter Gibbs, Brian James, Garth Powis, Keith B Nolop, Suman Bhattacharya, Leonard Saltz
发表日期
2015/12/1
期刊
Journal of clinical oncology
卷号
33
期号
34
页码范围
4032-4038
出版商
American Society of Clinical Oncology
简介
Purpose
BRAF V600E mutation is seen in 5% to 8% of patients with metastatic colorectal cancer (CRC) and is associated with poor prognosis. Vemurafenib, an oral BRAF V600 inhibitor, has pronounced activity in patients with metastatic melanoma, but its activity in patients with BRAF V600E–positive metastatic CRC was unknown.
Patients and Methods
In this multi-institutional, open-label study, patients with metastatic CRC with BRAF V600 mutations were recruited to an expansion cohort at the previously determined maximum-tolerated dose of 960 mg orally twice a day.
Results
Twenty-one patients were enrolled, of whom 20 had received at least one prior metastatic chemotherapy regimen. Grade 3 toxicities included keratoacanthomas, rash, fatigue, and arthralgia. Of the 21 patients treated, one patient had a confirmed partial response (5%; 95% CI, 1% to 24%) and seven other patients had stable disease by …
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S Kopetz, J Desai, E Chan, JR Hecht, PJ O'Dwyer… - Journal of clinical oncology, 2015